510(k) K142865 ยท DQA Oximeter
Nellcor Bedside SpO2 Patient Monitoring System
| Applicant | Covidien, LLC, Boulder CO, US |
| Decision | Substantially Equivalent, Mar 26, 2015 |
| Received | Sep 30, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142865
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2025 | Covidien Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941,
10005941J, 10005941JP, 10005941JPN Open, Classified |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.